K050578 is an FDA 510(k) clearance for the COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE. This device is classified as a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II - Special Controls, product code KNS).
Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on April 22, 2005, 46 days after receiving the submission on March 7, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K050578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2005 |
| Decision Date | April 22, 2005 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |